Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

NCT00758069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-05-05

Study results available
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Summary

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Conditions

  • Diabetes Mellitus, Non-Insulin-Dependent

Interventions

DRUG

sitagliptin phosphate

100 mg once daily (QD), taken orally for 4 weeks

DRUG

Comparator: Placebo

Placebo tablet, QD, taken orally for 4 weeks

DRUG

Comparator: Sitagliptin

50 mg twice daily (BID), taken orally for 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-03
Primary Completion
2006-02-13
Completion
2006-02-13

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00758069 on ClinicalTrials.gov